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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02559986
Other study ID # 1111007501
Secondary ID
Status Completed
Phase N/A
First received September 23, 2015
Last updated September 23, 2015
Start date January 2012
Est. completion date December 2014

Study information

Verified date September 2015
Source Indiana University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

Postpartum depression (PD) is a serious and disabling mental health condition that affects 10-15% of women after childbirth. Low-income minority women are disproportionately affected. Untreated PD can lead to significant negative outcomes for both mother and child. Pediatricians are being asked to routinely screen for PD and while screening rates are improving, little is known about whether mothers actually adhere to pediatrician recommendations to seek additional help after a positive PD screen. The objective of this study is to describe the rate at which mothers seek treatment for suspected PD after a positive screen at the pediatrician office. Additional examination will look at factors that predict whether a mother recalls a recommendation to seek treatment.


Description:

The primary outcome of interest is whether mothers suspected of having PD seek treatment after discussion with the pediatrician. In order to evaluate whether discussion with pediatricians leads mothers to seek care, data collection efforts should focus on what information was exchanged, the level of shared decision-making about possible treatment options and whether an agreed upon plan was reached between both parties. The investigators will examine the effectiveness of these discussions by interviewing mothers who were suspected of having PD and referred for treatment. The investigators hypothesize that pediatricians who are able to engage mothers in a shared decision will result in more of those mothers seeking help and getting into appropriate treatment for PD.

The specific research aims of this proposal are to:

Aim 1: Describe the rate at which mothers suspected by pediatricians of having PD seek treatment.

Aim 2: Explore what factors predict whether mothers suspected of PD seek treatment, including maternal sociodemographic characteristics, family centeredness of pediatrician care, and extent of shared decision-making strategy used by the pediatrician.

This will be a cohort study examining the rate at which mothers suspected of having PD seek care and the relationship between shared decision-making and seeking mental health care. Data for both specific aims will be collected by a single telephone interview with mothers suspected of having PD by the pediatrician and referred. For this study, investigators will be focusing recruitment efforts in the four Wishard community health centers (now Eskenazi Health) that use CHICA. In 2007, these four clinics saw 8,528 patients between the ages of 0 and 3 years. These clinics serve a large proportion of families that are underserved, economically disadvantaged and are ethnically and racially diverse.


Recruitment information / eligibility

Status Completed
Enrollment 73
Est. completion date December 2014
Est. primary completion date December 2014
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria:

-mothers with a positive PD screen who brought their child to seek medical care at participating study clinics, who were present for a majority of the child's visits.

Exclusion Criteria:

-not biological mother, did not bring child to majority of clinic visits

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional


Related Conditions & MeSH terms


Intervention

Other:
telephone interview
telephone interview about their care received during the first year of life and associated events

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Indiana University

Outcome

Type Measure Description Time frame Safety issue
Primary Rate at which mothers sought treatment for suspected PD Defined broadly as a positive response to either called adult care provider (primary care provider, obstetrician, or mental health therapist) for appointment or community resource Within 1 year of index visit No
Secondary Factors associated with help seeking behavior socio-demographics and other characteristics Within 1 year of index visit No
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